Cleared Traditional

K950652 - OSTEOTECH NAVICULAR AND CANCELLOUS CANNULATED SCREWS

K950652 is an FDA 510(k) clearance for OSTEOTECH NAVICULAR AND CANCELLOUS CANN..., manufactured by Osteotech, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K950652 · Osteotech, Inc. · Orthopedic device
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Jun 1995
Decision
129d
Days
Class 2
Risk

K950652 is an FDA 510(k) clearance for the OSTEOTECH NAVICULAR AND CANCELLOUS CANNULATED SCREWS. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Osteotech, Inc. (Shrewsbury, US). The FDA issued a Cleared decision on June 22, 1995 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Osteotech, Inc. devices

FDA 510(k) Submission Details - K950652

510(k) Number K950652 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 13, 1995
Decision Date June 22, 1995
Days to Decision 129 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 122d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HWC Screw, Fixation, Bone

All 929
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K950652.
LMT BONE ANCHOR
K951233 · Li Medical Technologies, Inc. · Jul 1995
LMT BONE ANCHOR
K951472 · Li Medical Technologies, Inc. · Jul 1995
K4 BONE SCREW SYSTEM
K950704 · Kinetikos Medical, Inc. · Jun 1995
SYNTHES 2.7 MM CANNULATED SCREW AND THREADED WASHER
K951304 · Synthes (Usa) · Jun 1995
IMPROVED PASSIVATION METHOD FOR METALLIC ORTHOPAEDIC IMPLANTS
K934590 · Smith & Nephew Richards, Inc. · Jun 1995
LINVATEC STASYS-PES FIXATION DEVICE
K934321 · Linvatec Corp. · May 1995